FDA WARNING_LETTER - www.cigarettesforsale.org

The FDA's Center for Tobacco Products issued a Warning Letter to the operator of http://www.cigarettesforsale.org after reviewing the website and determining that "555 Cigarettes" were offered for sale to U.S. customers. The FDA classified these as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was that the "555 Lights cigarettes" product was promoted as a modified risk tobacco product without an FDA order, rendering it adulterated under section 902(8) of the FD&C Act. Specifically, the use of the descriptor "Lights" in the product name and advertising classifies it as a modified risk tobacco product under section 991(b)(2)(A)(ii) of the FD&C Act. Section 911(a) prohibits the introduction or delivery of such products into interstate commerce without an FDA order under section 911(g).

The letter requires immediate correction of these violations and any similar issues to ensure compliance with the FD&C Act. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention and refusal of admission. A written response detailing corrective actions, including dates of discontinued violative promotion, and a plan for maintaining